Actively Recruiting
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients Treated With Chelators or Zinc Salts
Led by Hospices Civils de Lyon · Updated on 2026-01-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Wilson's Disease is a genetic disorder that causes copper to build up mainly in the liver and brain. Researchers are studying how urinary copper levels vary throughout the day in patients with Wilson's Disease who are treated with medicines that remove copper or reduce its absorption. The goal is to find the best time of day to measure copper in urine to better estimate the body's copper load and adjust treatment. The study involves three groups of patients aged 6 to 70 years, all confirmed to have Wilson's Disease. Each group is treated with one of three treatments: D-Penicillamine, Trientine, or Zinc salts. Patients will provide three urine samples collected over 8-hour periods and one blood sample to assess liver function and copper levels. The study is observational and aims to compare spot urine copper levels at different times with the standard 24-hour urine copper measurement. Participants will undergo urine and blood tests to measure copper excretion and liver function. Researchers will analyze the correlation between different urine collection periods and the standard 24-hour urine copper levels. This monitoring will help determine the optimal urine collection time for evaluating copper elimination. The study will last until February 2027, and participants must be able to perform 24-hour urine collection as part of the study assessments.
CONDITIONS
Brief Title
Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a confirmed diagnosis of Wilson's Disease (Leipzig score ≥ 4).
- Age between 6 and 70 years.
- Able to perform 24-hour urine collection.
- Currently treated with D-Penicillamine, Trientine, or Zinc.
- Non-opposition from patient or legal representatives for minors.
You will not qualify if you...
- Treatment change within the last 6 months before inclusion.
- History of liver transplantation.
- Known chronic renal failure with GFR less than 30 ml/min.
- On long-term diuretic or corticosteroid therapy.
- Persons deprived of liberty by judicial or administrative decision.
- Patients under judicial protection unable to consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single day
Participants provide urine and blood samples to assess copper excretion and liver function.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Service de Gastroentérologie, Hépatologie et Nutrition Pédiatriques - Hôpital Femme Mère Enfant
Bron, Rhone, France, 69500
Actively Recruiting
Research Team
E
Eduardo COUCHONNAL, Dr
A
Abdelouahed BELMALIH, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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